Product Development · Case Study
A specialized enclosure for diagnostic equipment, designed and prototyped to the client's regulatory and end-user requirements.
About the project
A medical diagnostic equipment maker needed an enclosure for a new device — one that had to protect sensitive internal electronics, support cleaning protocols specified by the client's regulatory team, and feel trustworthy to a clinician using it every day. Every dimension and material choice had to trace back to a documented requirement, since this was ultimately going through the client's own regulatory submission process.
Mazi Inc. worked directly against the client's requirements documentation, designing and prototyping the enclosure in iterations the client's regulatory and clinical teams could review at each stage.
Our approach
On a regulated product, every design decision needs a paper trail back to a requirement — not a designer's preference. We treated the client's requirements documentation as the actual specification, and flagged anywhere our design judgment was filling a gap so their regulatory team could confirm it explicitly rather than discover it later.
The enclosure was developed through staged prototypes — a form-and-fit model, then a functional prototype for thermal and cleaning validation, then a pre-production version — with the client's clinical and regulatory contacts reviewing at each stage rather than only at the end.
What worked
What we navigated
Looking back
Flagging assumptions explicitly, instead of quietly resolving ambiguous requirements ourselves, turned out to be the highest-value habit on this project — it meant the client's regulatory team was never surprised by a decision they hadn't actually signed off on. Staged prototyping with real clinical review at each step also caught usability issues far cheaper than a single end-of-project review would have.
Why Mazi Inc.
Every choice ties back to a documented requirement your regulatory team can review.
Form, function, and pre-production stages built in, so review happens before problems are locked in.
Enclosures are designed for the clinician using them, alongside the requirements document.
Send your requirements documentation and current design stage. We'll help scope the design and prototyping plan.